Guidelines for Stability Testing of Post-Approval Changes
1) Purpose
The purpose of this Standard Operating Procedure (SOP) is to outline the process for conducting stability testing for post-approval changes to drug substances and products in accordance with US FDA guidelines. This SOP ensures that any changes made after approval do not adversely affect the product’s quality, safety, or efficacy.
2) Scope
This SOP applies to all personnel involved in the stability testing of drug substances and products following any post-approval changes, such as changes in manufacturing, formulation, packaging, or storage conditions, intended
3) Responsibilities
Stability Testing Team: Responsible for conducting stability studies, collecting data, and documenting results in compliance with US FDA guidelines.
Quality Assurance (QA) Team: Responsible for reviewing and approving stability protocols and reports, ensuring compliance with regulatory requirements.
Regulatory Affairs Team: Responsible for
4) Procedure
4.1 Preparation for Stability Testing
4.1.1 Identify the nature of the post-approval change (e.g., formulation change, manufacturing site change, packaging change) and its potential impact on product stability.
4.1.2 Review the US FDA guidance documents for the stability testing requirements specific to the type of post-approval change.
4.1.3 Develop a stability protocol that includes study design, testing schedule, storage conditions, and testing parameters based on the change being implemented.
4.2 Selection of Batches and Samples
4.2.1 Select representative batches of the modified product that incorporate the post-approval change.
4.2.2 Prepare sufficient samples to cover the entire study duration, considering the number of time points and tests to be conducted.
4.3 Conducting the Stability Studies
4.3.1 Store samples under the defined conditions, monitoring temperature, humidity, and other relevant environmental factors.
4.3.2 At each specified time point, conduct stability-indicating tests to assess the impact of the post-approval change on the product’s quality, safety, and efficacy.
4.3.3 Record all results meticulously in stability data sheets, ensuring accuracy and traceability of data.
4.4 Data Analysis and Reporting
4.4.1 Review the stability data to identify any trends, deviations, or out-of-specification (OOS) results that may indicate an adverse impact due to the change.
4.4.2 Compile a stability report that includes the study design, results, conclusions, and recommendations for maintaining the approved shelf life and storage conditions.
5) Abbreviations, if any
US FDA: United States Food and Drug Administration
QA: Quality Assurance
OOS: Out-of-Specification
6) Documents, if any
Stability protocol, stability data sheets, stability testing records, stability report, submission package to regulatory authorities.
7) Reference, if any
US FDA Guidance for Industry: Stability Testing of Drug Substances and Drug Products, CFR Title 21, ICH Guidelines.
8) SOP Version
Version 1.0